Noncompliance that is neither serious nor continuing.

Research study in which the same research procedures are performed at multiple sites. There is often a lead institution that is the prime recipient of the…

An investigational device that does not meet the definition of a significant risk device. This is not the same as the concept of “minimal risk” as…

An action or omission on the part of the researcher or IRB that is inconsistent with any of the following: The ethical principles of human subjects…

The clinical use of an FDA-approved drug, device or biologic for a purpose or population that has not been approved by the FDA, or in a…

The total number of subjects enrolled in a study is greater than was approved in the initial IRB application or in a subsequent modification.

The agreement of parent(s) or guardian to the participation of their child or ward in research.

The date when the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the…

An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and…

An IRB member who has a close working knowledge, understanding, and appreciation of conditions from the perspective of prisoners. The prisoner advocate may be a former…

Privacy is about having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. It includes: a sense of being…

This is the equivalent of a federal Certificate of Confidentiality, but it is provided (and required by) the federal Department of Justice (DOJ) for any research…

Prospect of direct benefit refers to the potential for a positive outcome (e.g., cure of disease, pain relief, increased mobility) for the individual participant resulting from…

Any information (verbal, paper or electronic) maintained or transmitted by a covered entity (a health plan, healthcare clearinghouse, or health care provider) that relates to: the…

This refers to children, prisoners, pregnant women, nonviable neonates, and neonates of uncertain viability.  These groups are protected by specific additional protections described in some federal…

Protection of Pupil Rights Amendment. This federal law applies to all children not over age 21 who are in elementary or secondary programs and institutions that…

At the University of Washington, the Radiation Safety Office is the operational arm of the University Radiation Safety Committee and is responsible for developing and carrying…

This committee is established at an institution and approved by the Food and Drug Administration (FDA) for the purpose of approving and monitoring the use of…

An Institutional Review Board (IRB) member’s absence from the IRB meeting due to a conflict of interest with respect to the item under consideration. The member…

Also called an authorization agreement. Refers to agreements with other institutions or individuals about who will conduct the Institutional Review Board (IRB) review of all or…